National Family Farm Coalition v. Vilsack

District Court, N.D. California·Decided December 2, 2024·No. 3:21-cv-05695·Unknown

Opinion

NATIONAL FAMILY FARM COALITION Case No. 21-cv-05695-JD et al., Plaintiffs, ORDER RE SUMMARY JUDGMENT v. TOM VILSACK et al., Defendants.

In 2004, the Animal and Plant Health Inspection Service (APHIS), housed within the U.S. Department of Agriculture (USDA), announced the intention to revisit regulations governing genetically engineered (GE) organisms. APHIS published a notice of proposed rulemaking in 2008 that kicked off over a decade of activity and concluded in a final rule the agency adopted in May 2020. Plaintiffs, who are non-profit and public-interest groups organized around concerns for farmers, crops, food safety, and the environment, object to the final rule. In plaintiffs’ view, the final rule effectively abandoned federal government regulation of GE organisms, leaving GE crop developers and agribusinesses to their own devices without adequate safety and other oversight. Plaintiffs ask to set aside the final rule under the Administrative Procedure Act on the ground that APHIS acted arbitrarily and capriciously, and contrary to various federal statutes. See generally Dkt. No. 1. Summary judgment is granted in part to plaintiffs. The rule is vacated and remanded to the agency for further consideration in a manner consistent with this order.

In 1986, the Office of Science and Technology Policy promulgated a Coordinated Framework for the Regulation of Biotechnology, under which regulatory jurisdiction over emerging developments in genetic engineering was delegated to three agencies: (1) the USDA, and specifically APHIS; (2) the Environmental Protection Agency, and (3) the Food and Drug Administration. See Movement of Certain Genetically Engineered Organisms, 85 Fed. Reg. 29790, 29790 (May 18, 2020) (codified at 7 C.F.R. §§ 330, 340, & 372). At that time, three federal statutes were the keystones of overseeing our national agricultural resources: the Plant Quarantine Act of 1912 (PQA), Pub. L. No. 62-275, 37 Stat. 315; the Federal Plant Pest Act of 1957 (FPPA), Pub. L. No. 85-36, 71 Stat. 31; and the Federal Noxious Weed Act of 1974 (FNWA), Pub. L. No. 93-629, 88 Stat. 2148. In 2000, Congress enacted the Plant Protection Act (PPA), Pub. L. No. 106-224, 114 Stat. 438, which consolidated the FPPA, PQA, and FNWA into a unitary statutory scheme. The PPA authorizes the Secretary of Agriculture (Secretary), who has delegated her authority to APHIS, see 7 C.F.R. §§ 371.1, 371.3, to regulate plant pests and noxious weeds and requires the agency to “facilitate exports, imports, and interstate commerce in agricultural products and other commodities that pose a risk of harboring plant pests or noxious weeds in ways that will reduce, to the extent practicable, as determined by the [agency], the risk of dissemination of plant pests or noxious weeds.” 7 U.S.C. § 7701(3). The statute defines a “plant pest” as an organism “that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product.” Id. at § 7702(14). The movement of “any plant pest” without a “permit” is prohibited, id. at § 7711(a), although the agency may suspend permitting requirements for “specified plant pests . . . if the [agency] finds that a permit . . . is not necessary,” id. at § 7711(c). The PPA defines “noxious weed” as “any plant or plant product that can directly or indirectly injure or cause damage to crops (including nursery stock or plant products), livestock, poultry, or other interests of agriculture, irrigation, at § 7702(10). The agency is authorized to “prohibit or restrict the . . . movement in interstate commerce of any . . . noxious weed” as “necessary.” Id. at § 7712(a). The statute contemplates permitting requirements for noxious weeds and authorizes the agency to “publish, by regulation, a list of noxious weeds that are prohibited or . . . subject to restrictions.” Id. at § 7712(c), (f). APHIS regulates GE plants under 7 C.F.R. § 340. The regulations date back to 1987, when APHIS first imposed a pre-market authorization requirement and other measures for GE plants if the plants were classified as a “plant pest” under the then-controlling FPPA. 85 Fed. Reg. at 29790; see generally Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There is Reason to Believe Are Plant Pests, 52 Fed. Reg. 22892 (June 16, 1987). A GE plant was classified as a “plant pest” if “it [was] created using an organism that is itself a plant pest,” Ctr. for Food Safety v. Vilsack, 718 F.3d 829, 835 (9th Cir. 2013), and so the rule covered most GE plants at the time because the predominant engineering technique used plant-pest material to introduce new genetic characteristics to the target plant, see Movement of Certain Genetically Engineered Organisms, 84 Fed. Reg. 26514, 26521 (June 6, 2019). Under the part 340 regulations, plant pests could not be moved interstate or introduced into the environment without notification and a permit, and permitting conditions included record-keeping and labeling requirements. See, e.g., Importation, Interstate Movement, and Release into the Environment of Certain Genetically Engineered Organisms, 73 Fed. Reg. 60008, 600010-11 (Oct. 9, 2008). The regulatory scheme reflected a presumption of “plant pest risk, until proven otherwise,” due to the means by which genetic material was introduced into the target plant. Dkt. No. 60 at 6. Between 1987 and the start of the rulemaking process at the heart of this lawsuit, the regulations were revised several times to lessen the regulatory burden on some GE plants. See 84 Fed. Reg. at 26514. For example, one set of revisions provided that GE-plant developers could introduce or move in interstate commerce certain crop species without obtaining a permit if certain eligibility requirements were met and the developer went through the agency’s notification Procedures for the Introduction of Certain Regulated Articles; and Petition for Nonregulated Status, 58 Fed. Reg. 17044 (Mar. 31, 1993). Other revisions created a process through which GE- plant developers could petition for deregulation from section 340 altogether by submitting to the agency extensive data pertaining to the GE plant’s plant-pest risk. See generally id. In all of the revisions, GE plants were treated as plant pests for regulatory purposes and so were not subject to the permitting or pre-market-authorization requirements that applied to noxious weeds. APHIS regulated, and continues to regulate, noxious weeds under 7 C.F.R. § 360 and prohibits the unauthorized movement of any plant designated as a noxious weed by the Secretary of Agriculture. See id. § 360.300. By its own terms, part 360 regulates noxious weeds by taxon, which is defined as “[a]ny grouping within botanical nomenclature, such as family, genus, species, or cultivar.” See 7 C.F.R. §§ 360.100 (defining “taxon”), 360.200, 360.500-01. The result, then, is that a plant’s GE and non-GE counterparts are treated identically for noxious- weed purposes. Cf. id. at § 360.200 n.1. APHIS does not dispute plaintiffs’ statement that, with

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